ZIMMER DERMATOME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-19 for ZIMMER DERMATOME manufactured by Zimmer Surgical, Inc..

Event Text Entries

[186696764] This event has been recorded by zimmer biomet under (b)(4). Once the investigation is completed, a follow-up/final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[186696765] It was reported that the current issue with this dermatome was believe to be a design flaw. The new models have a single locking screw on the underside of the unit to secure in the dermatome blade and protective guard plate. Due to this design, once the screw is tightened in place, there is a very clear centrally located pressure on the floppy blade which ultimately allows for normal apposition at the center of the guard, with the blade bending/bowing out at the lateral edges. The result is in varying, non-uniform depths of harvested graft take, skipping and poor cosmesis. No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001526350-2020-00292
MDR Report Key9856982
Report SourceOTHER,USER FACILITY
Date Received2020-03-19
Date of Report2020-03-18
Date of Event2020-02-26
Date Mfgr Received2020-03-16
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER SURGICAL, INC.
Manufacturer Street200 WEST OHIO AVENUE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal Code44622
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameZIMMER DERMATOME
Generic NameDERMATOME
Product CodeGFD
Date Received2020-03-19
Catalog NumberNI
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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